- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376525
Comparison of Ventilatory Effects of Ultrasound-Guided Versus Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy
Comparison of the Effects of Percutaneous Dilatational Tracheostomy Performed With Fiberoptic Bronchoscopy and Ultrasound Guidance on Ventilation
Percutaneous dilatational tracheostomy (PDT) is a commonly performed procedure in intensive care units for patients requiring prolonged mechanical ventilation. Fiberoptic bronchoscopy (FOB) and ultrasonography (USG) are frequently used to guide PDT in order to improve procedural safety. However, the effects of these guidance techniques on ventilation parameters during the procedure remain unclear.
This retrospective observational study aims to compare the effects of FOB-guided and USG-guided percutaneous dilatational tracheostomy on ventilation parameters in mechanically ventilated adult intensive care unit patients. Changes in arterial blood gas parameters and ventilator settings during and after the procedure will be evaluated.
The findings of this study may help clinicians better understand the physiological effects of different PDT guidance techniques and support informed decision-making in clinical practice.
Study Overview
Status
Intervention / Treatment
Detailed Description
Percutaneous dilatational tracheostomy (PDT) is widely used in intensive care units (ICUs) as an alternative to surgical tracheostomy in patients requiring prolonged mechanical ventilation. Various guidance methods have been introduced to increase procedural safety and accuracy, including fiberoptic bronchoscopy (FOB) and ultrasonography (USG). While both techniques are commonly used, their effects on ventilation and gas exchange during the procedure are still debated.
Fiberoptic bronchoscopy allows direct visualization of the tracheal lumen and needle placement but may partially obstruct the airway, potentially leading to increased airway pressures, hypercapnia, and impaired ventilation. Ultrasonography, on the other hand, enables real-time visualization of neck anatomy without entering the airway and may therefore have different effects on ventilation parameters.
This retrospective observational study includes adult ICU patients who underwent percutaneous dilatational tracheostomy between May 5, 2023, and September 1, 2025. Patients were grouped according to the guidance technique used during the procedure: FOB-guided PDT or USG-guided PDT. All procedures were performed under standard ICU conditions by experienced clinicians.
Demographic data, clinical characteristics, ventilator settings, and arterial blood gas parameters were collected from patient records. Primary outcomes included changes in arterial blood gas values (pH, PaCO₂, PaO₂) and ventilatory parameters before, during, and after the procedure. Secondary outcomes included procedure duration and procedure-related complications.
The study aims to compare the effects of FOB-guided and USG-guided PDT on ventilation and gas exchange, providing insight into the physiological consequences of each technique. As a retrospective observational study, no additional interventions were performed beyond standard clinical practice.
The results of this study may contribute to optimizing guidance method selection during percutaneous dilatational tracheostomy and improving patient safety in the intensive care setting.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sisli
-
Istanbul, Sisli, Turkey (Türkiye), 34384
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult patients (≥18 years of age) Patients admitted to the intensive care unit Patients receiving invasive mechanical ventilation Patients who underwent percutaneous dilatational tracheostomy under fiberoptic bronchoscopy or ultrasonography guidance Availability of complete clinical and arterial blood gas data
Exclusion Criteria:
Age <18 years Patients with incomplete medical records or missing arterial blood gas data Patients who underwent surgical (open) tracheostomy Patients with pre-existing tracheal pathology affecting ventilation parameters
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy
Adult ICU patients who underwent percutaneous dilatational tracheostomy guided by fiberoptic bronchoscopy as part of routine clinical practice.
|
Percutaneous dilatational tracheostomy performed under either fiberoptic bronchoscopy or ultrasonography guidance according to routine clinical practice.
No interventions were assigned by study protocol.
|
|
Ultrasonography-Guided Percutaneous Dilatational Tracheostomy
Adult ICU patients who underwent percutaneous dilatational tracheostomy guided by ultrasonography as part of routine clinical practice.
|
Percutaneous dilatational tracheostomy performed under either fiberoptic bronchoscopy or ultrasonography guidance according to routine clinical practice.
No interventions were assigned by study protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ventilation and Arterial Blood Gas Parameters During Percutaneous Dilatational Tracheostomy
Time Frame: Immediately before the procedure, during the procedure, and immediately after the procedure
|
Changes in arterial blood gas parameters (pH, PaCO₂, PaO₂) and ventilatory parameters measured before, during, and after percutaneous dilatational tracheostomy, comparing fiberoptic bronchoscopy-guided and ultrasonography-guided procedures.
|
Immediately before the procedure, during the procedure, and immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure Duration
Time Frame: During the procedure
|
Total duration of the percutaneous dilatational tracheostomy procedure, measured from skin incision to successful tracheostomy tube placement.
|
During the procedure
|
|
Procedure-Related Complications
Time Frame: During the procedure and the immediate post-procedural period
|
Incidence of procedure-related complications, including hypoxia, hypercapnia, bleeding, hypotension, pneumothorax, and other clinically relevant adverse events.
|
During the procedure and the immediate post-procedural period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-ERHO-AR-BA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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